{"id":1796,"date":"2020-01-10T15:45:15","date_gmt":"2020-01-10T15:45:15","guid":{"rendered":"http:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/?p=1796"},"modified":"2022-04-13T13:59:10","modified_gmt":"2022-04-13T13:59:10","slug":"eu-clinical-trial-regulation-conference","status":"publish","type":"post","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/eu-clinical-trial-regulation-conference\/","title":{"rendered":"EU Clinical Trial Regulation Conference"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><strong>Background<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In early December 2019 I was lucky enough to attend a conference on the EU Clinical Trial Regulation run by the Drug Information Association. Not only did I get to experience the great city of Amsterdam, but I also got to be part of a well delivered and informative conference with lots of colleagues from around the world from all sorts of companies and institutions. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">For those of you who are familiar with the area of Regulatory Affairs and Pharmacovigilance you will know that finding any sort of training\/ learning event that is worth attending is almost impossible.&nbsp; So, this ticked all the boxes as well as being informative it was a great networking opportunity (you can imagine my delight when I was able to pick the brains of someone who works in pharmacovigilance in vaccines at Glaxosmithkline).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>A<\/strong> <strong>busy programme <\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Day One agenda<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Status on implementation of the EU Clinical\nTrial Regulation and how to keep momentum<\/li><li>Innovative Trial Designs and their Management<\/li><li>Experiences from National Pilots information and\nLearnings<\/li><li>Clinical Trial Regulation and Ethics Committee\npreparedness<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Day Two agenda <\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\"><li>Safety Reporting \u2013 Guidance on use of the new\nRSI and outstanding issues<\/li><li>GDPR and its consequences for clinical trials<\/li><li>Update on the EU portal from the user\u2019s\nperspective<\/li><\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">The two sessions I found the most interesting were the safety reporting and the GDPR session. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">GDPR session<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The GDPR session was given by a solicitor from UK firm Baker and McKenzie and provided a great overview of GDPR and the different interpretation of the regulations throughout Europe.&nbsp; The new GDPR regulations are set out in European legislation but this has been interpreted differently in national law throughout Europe.&nbsp; The consensus was that in general the research community are struggling to be GDPR compliant as pseudonymised and coded data is no longer outside of GDPR.&nbsp; Pseudonymised data is coded if you can reidentify a person based on other datasets available (often sites hold this key).&nbsp; This is where a split comes in; UK and France say that sites are processors only and this is the standardised view with the sponsor as the controller. In Spain, Italy, Netherlands and Germany there is guidance and legislation issued to say that sites are data controllers, and this is always the case. The presentation then went on to cover identifying an adequate legal basis for processing personal health data in clinical trials and consent in clinical trials.&nbsp; The presentation really highlighted to me the challenges we may face at the CTR as we look to expand our trials out internationally.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">Safety session<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The main benefit of me attending the safety session\nwas that nothing was said that was a huge surprise and having worked in the\narea of PV now for several years and lived through several PV specific MHRA\ninspections it was nice that there were no \u2018shockers\u2019 so to speak. In summary &#8211;\nFatal and Life-threatening SARs should always be considered unexpected as a\nrule as it has an impact on the benefit to risk ratio of the clinical trial.\nFatal SARs can only be considered expected if clearly detailed in the SPC and\nadequate risk mitigation measures need to be taken. Life threatening SARs can\nbe in the RSI if strongly justified. By agreeing to use an RSI we are\neffectively agreeing to those events listed as not being SUSARs<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Participant Information\nSheets <\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Nearly every session\nraised a point about patient information sheets. There was a feeling that\nPatient Information Sheets are becoming too long and unmanageable particularly\nwhen we also fill them with all the information regarding GDPR.&nbsp; A suggestion was that we considered a layered\napproach for example with all the information regarding GPR being in one\ninformation sheet and all the trial specific information being in another.&nbsp; It was also suggested we could also look at\nproviding more signposting to websites for information rather than trying to\ninclude all the information in the PIS. One ethics representative said he felt\nlike the patient information sheet was no longer an information sheet but an\nattempt at forming a contract with the patient. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Consent and\nwithdrawal <\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">In the UK HRA\nguidance explicitly tells you not to rely on GDPR consent as your main legal\nbasis for processing and this is the same as the guidance issued in France.&nbsp; The GDPR sets a high bar for consent and a\nparticipant right to withdraw consent. If you use consent as your main legal\nbasis for processing if the participant withdraws consent, then you are meant\nto stop all processing activities going forward and delete the data. Therefore,\nwe need a different main legal basis for processing. There are lots of issues\nwith GDPR consent and other grounds should be relied upon.&nbsp; <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">However, Spain has a\nrequirement for explicit consent and in Germany the ethics committees are\nfeeding back that they feel GDPR has heightened the need for consent not\nnegated it.&nbsp; It appeared a multi-site\nmulti country uniform approach to data privacy compliance isn\u2019t possible and\nshould be considered on a jurisdiction by jurisdiction basis. <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Complex trial\ndesign<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Several presentations revolved around the \u2018Recommendation Paper on the Initiation and Conduct of Complex\nClinical Trials Clinical Trials Facilitation\nand Coordination Group (CTFG) Published: 12 February\n2019\u2019 and the best way to design clinical complex\ntrials.&nbsp; <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">CTFG had some key recommendations for initiation and conduct of complex clinical trials:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">1. Clearly describe and justify\ndesign<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2. Maintain scientific integrity<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. Ensure quality of trial conduct\nand optimise clinical feasibility<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. Ensure safety of trial subjects<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. Maintain data integrity<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">6. Reassess benefit-risk balance\nat critical steps throughout clinical trial<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">7. Validate companion diagnostics<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">8. Consider data transparency<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Summary<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A clear emphasis ran\nthrough the conference that focused on openness in clinical trials, publishing\nresults, patient information, involving lay people, data transparency and\npatient safety and these are things that we could benefit from keeping in mind\nwhenever we are developing trials at the CTR regardless of the impact the new EU\nclinical trials regulations may or may not have on us. <\/p>\n","protected":false},"excerpt":{"rendered":"Background In early December 2019 I was lucky enough to attend a conference on the EU Clinical Trial Regulation run by the Drug Information Association. Not only did I get [&hellip;]","protected":false},"author":1769,"featured_media":1799,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7],"tags":[96,94,95],"class_list":["post-1796","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-events","tag-gdpr","tag-qa","tag-safety"],"jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p7dIou-sY","jetpack-related-posts":[{"id":1609,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/the-changing-landscape-of-medical-devices-and-clinical-investigations-medical-devices-regulation-mdr\/","url_meta":{"origin":1796,"position":0},"title":"The Changing Landscape Of Medical Devices And Clinical Investigations: Medical Devices Regulation (MDR)","author":"Claire Johnson","date":"April 12, 2019","format":false,"excerpt":"Background A strong contingent of Centre for Trials Research staff, including representation from trial managers, senior trial managers, pharmacovigilance and safety, and quality assurance attended the medical devices training day hosted by Health Care Research Wales and presented by Professor Pete Wall in March 2019.\u00a0 This is reflective of our\u2026","rel":"","context":"In &quot;Medical Devices&quot;","block_context":{"text":"Medical Devices","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/medical-devices\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/04\/the-level-of-sugar-in-the-blood-3310318_1920.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":3021,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/centre-for-trials-research-at-ictmc2024-7th-international-clinical-trials-methodology-conference-ictmc\/","url_meta":{"origin":1796,"position":1},"title":"Centre for Trials Research At #ICTMC2024: 7th International Clinical Trials Methodology Conference (ICTMC)","author":"Helen Stanton","date":"November 26, 2024","format":false,"excerpt":"- Helen Stanton, Waku Maboshe and Fiona Lugg-Widger This year, the bi-annual International Clinical Trials Methodology Conference (ICTMC) was held in the beautiful and historic city of Edinburgh, Scotland. Held at Edinburgh\u2019s International Conference Centre, proceedings took place from the 30th of September to the 3rd of October 2024. The\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"Centre for Trials attendees at ICTMC 2024","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/11\/Photo1-CTR.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/11\/Photo1-CTR.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2024\/11\/Photo1-CTR.jpg?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":1645,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/clinical-trials-as-a-catalyst-for-change-in-the-big-easy-the-40th-society-for-clinical-trials-annual-meeting-new-orleans-usa\/","url_meta":{"origin":1796,"position":2},"title":"Clinical Trials As A Catalyst For Change In The \u2018Big Easy\u2019 \u2013 The 40th Society For Clinical Trials Annual Meeting, New Orleans, USA","author":"Victoria Shepherd","date":"June 13, 2019","format":false,"excerpt":"By Victoria Shepherd and Nigel Kirby A taste of New Orleans At times New Orleans felt very much like Wales\u2026\u2026 wet. However, when the sun came out and the puddles dried up New Orleans was a place full of culture and friendly faces. The French Quarter is a vibrant place\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/06\/New-Orleans-SCT.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/06\/New-Orleans-SCT.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/06\/New-Orleans-SCT.png?resize=525%2C300&ssl=1 1.5x"},"classes":[]},{"id":1706,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/south-west-research-hub-event-meeting\/","url_meta":{"origin":1796,"position":3},"title":"South West Research Hub Event Meeting","author":"Richard Haggerty","date":"September 5, 2019","format":false,"excerpt":"South West Research Hub event meeting 5th September 2019 The 2nd South West Research Hub meeting was hosted by the Centre for Trials Research on Thursday 5th September 2019 in Cardiff University\u2019s Glamorgan Building. This year\u2019s theme was Trial Methodology. There were around 60 delegates from across the South West\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/09\/SW-Hub-Delegates-2019-scaled.jpg?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2396,"url":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/centre-for-trials-research-at-ictmc2022-6th-international-clinical-trials-methodology-conference-ictmc\/","url_meta":{"origin":1796,"position":4},"title":"Centre for Trials Research At #ICTMC2022: 6th International Clinical Trials Methodology Conference (ICTMC)","author":"Cheney Drew","date":"October 27, 2022","format":false,"excerpt":"After a Covid related hiatus, so a year later than planned, the bi-annual International Clinical Trials Methodology Conference (ICTMC) was held in the beautiful spa town of Harrogate at the beginning of October 2022. The ICTMC meeting is a great opportunity to learn about all things methodological in the clinical\u2026","rel":"","context":"In &quot;Events&quot;","block_context":{"text":"Events","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/events\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2022\/10\/ICTMC-2022.jpg?resize=700%2C400&ssl=1 2x, 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by the Chief Investigators (CIs), Dr Sacha Howell\u2026","rel":"","context":"In &quot;Cancer Trial&quot;","block_context":{"text":"Cancer Trial","link":"https:\/\/blogs.cardiff.ac.uk\/centre-for-trials-research\/category\/cancer-trial\/"},"img":{"alt_text":"Centre for Trials Research at ASCO","src":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/07\/IMG-20190604-WA0002.jpg?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/07\/IMG-20190604-WA0002.jpg?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/07\/IMG-20190604-WA0002.jpg?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/blogs.cardiff.ac.uk\/centre-for-trials-research\/wp-content\/uploads\/sites\/499\/2019\/07\/IMG-20190604-WA0002.jpg?resize=700%2C400&ssl=1 2x, 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